Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage (PURPOSE)

Prophylactic Amnioinfusion for Prevention of Postpartum Hemorrhage: A Randomized Clinical Trial (PURPOSE)

The purpose of this study is to decrease the likelihood of composite postpartum hemorrhage (PPH) morbidity, which consists of i) Estimated or quantified blood loss of 1,500 mL or more, ii) transfusion of any blood products or iii) hysterectomy

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Combination product: Saline delivered using an intrauterine pressure catheter (IUPC)

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sarah Mehl, MD; Phone Number: (712) 500-6412; Email: Sarah.Theriot@uth.tmc.edu
• Study Contact Backup: Name: Ahmed S Zaki Moustafa; Phone Number: (713) 500-6412; Email: Ahmed.ZakiMoustafa@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Ahmed S Zaki Moustafa; Phone Number: (713) 500-6412; Email: Ahmed.ZakiMoustafa@uth.tmc.edu
      • Contact: Sarah Mehl, MD; Phone Number: 712-500-6412; Email: Sarah.Theriot@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Singletons with a gestational age of 34.0 weeks or more
• Labor (spontaneous or medical induction)
• Medium- or High-risk for PPH, as described by American College of Obstetricians and Gynecologists (ACOG)

Exclusion Criteria:

• Scheduled cesarean delivery
• Multiple gestations
• Delivery at < 34.0 weeks
• Contraindication to place intrauterine pressure catheter (e.g. HIV)
• Incarcerated subjects
• Major fetal anomalies requiring neonatal surgical intervention
• Stillbirth on admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Care
Experimental: Prophylactic amnioinfusion	Combination product: Saline delivered using an intrauterine pressure catheter (IUPC); An intrauterine pressure catheter (IUPC) will be placed in participants after membrane rupture, or at 4 cm if membranes previously ruptured. A 300cc bolus of normal saline will be administered. A continuous rate of 100 cc/hr of normal saline will continue until delivery to prevent Postpartum Hemorrhage. If the IUPC is dislodged, it will be replaced by a trained clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who have estimated or quantified blood loss of 1,500 mL or more	from delivery admission to discharge (average of 3 days post delivery)
Number of participants who have transfusion of any blood products	from delivery admission to discharge or up to 12 weeks post delivery
Number of participants who have hysterectomy	from delivery admission to discharge or up to 12 weeks post delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of mothers who use uterotonics, in addition to oxytocin	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Estimated blood loss(mL)	post delivery (from immediately after delivery to upto 2 hours after delivery)
Quantitative blood loss(mL)	post delivery(from immediately after delivery to upto 2 hours after delivery)
Delta change in hemoglobin of mothers	pre delivery, post partum day 1
Number of mothers who have cesarean deliveries	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who need Mechanical tamponade	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have surgical interventions (O'Leary, B 'Lynch or uterine arterial embolization)	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have Chorioamnionitis	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have endometritis	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who have wound complications (if cesarean delivery)	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of mothers who are admitted to intensive care unit	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of deaths	from delivery admission to discharge or up to 12 weeks post delivery if participant is readmitted in the postpartum period
Number of neonates with Apgar < 7	at 5 minutes after delivery
Number of neonates that have a seizure	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have meconium aspiration syndrome	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Ventilation > 6 hrs	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Bronchopulmonary dysplasia	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Necrotizing enterocolitis	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of neonates that have Sepsis	delivery admission to discharge or upto 27 days after birth if neonate is readmitted with any of the complications
Number of stillbirths	at delivery
Number of deaths of neonates	within 27 days of birth

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sarah Mehl, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 11, 2024
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage
• Other Study ID Numbers: HSC-MS-24-0439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No